Peptide Intelligence · peptide
TB-500
Also: Thymosin beta-4 fragment, Tβ4
A synthetic fragment of thymosin beta-4, a naturally occurring protein involved in cell migration and wound healing. Marketed for recovery and injury.
Approval status
Not FDA-approved
Not FDA-approved.
Compounding status
PCAC-recommended (Jul 2026) · rulemaking pending
PCAC voted Jul 23–24 2026 to recommend adding to the 503A list; non-binding, rulemaking pending. Research-use-only products are unapproved drugs.
Evidence grade
C · Animal or in-vitro only
Animal studies; a small number of early human trials of full-length thymosin beta-4 for wound healing, not the fragment sold as TB-500.
If you already have a vial
Products sold as research-use-only are unapproved drugs. Nothing required the seller to verify identity, purity, sterility or concentration. That is the practical risk, more than the compound itself. Worth discussing with your clinician before you continue, and worth logging so your labs can be read against it.
Known risks and label warnings
- Unknown human safety
- Grey-market quality risk
Interactions people ask about
- Unknown
What people often measure
Framed as things to discuss with your clinician, not a protocol.
- Symptoms; baseline labs per clinician
Questions for your clinician
- Is the product I have full-length thymosin beta-4 or a fragment, and does that matter?
Get the full report by email
- The TB-500 status card, monitoring list and clinician questions, printable
- The pre-therapy baseline checklist: what people commonly measure before starting any injectable
- A note the next time FDA or HHS acts on this compound
Wellness guidance only, not medical advice. We never sell or dispense medication.
Regulatory timeline for TB-500
2026-07-24
PCAC votes to recommend six peptides for the 503A bulks list
The Pharmacy Compounding Advisory Committee voted in favor of BPC-157, TB-500, KPV, MOTS-c, Semax and epitalon. The votes are advisory only. Until FDA completes rulemaking, none of the six is legally compoundable and research-use-only products remain unapproved drugs.
FDA PCAC meeting page2026-04-15
Federal Register notice updates the peptide 'do not compound' list
FDA published an update to the Category 2 list and opened the process for nominated peptides to be evaluated for the 503A bulks list.
Frier Levitt analysis of the Apr 15 2026 notice2026-02-27
HHS announces a review of peptide compounding policy
HHS signaled it would revisit the compounding status of several peptides, setting up the April Federal Register notice and the July advisory-committee meeting.
Frier Levitt analysis
Sources and review
Status as of 2026-09-02. Reviewed 2026-09-02 by Curtis Holder (product); clinical review pending; next review due 2026-11-01. Regulatory status changes; we update this page after each FDA or HHS action. Wellness guidance only, not medical advice. Med.xyz does not sell, prescribe or recommend any compound.